# The Medicines (Products for Human Use) (Fees) Regulations 2012, Paragraph 21: Standard variation application for a homoeopathic medicinal product


A standard variation application for a homoeopathic medicinal product is an application for a variation of a marketing authorization for a national homoeopathic product which requires—
(a) the replacement of an excipient used in the manufacture of the product;
(b) the replacement of a reagent indirectly associated with the manufacturing process of the product or which disappears from that process with a comparable reagent;
(c) a change to the qualitative composition of the container or other form of packaging immediately in contact with the product;
(d) a change to the method of manufacture of a homoeopathic stock included in the product;
(e) a change to the specification of any reagent or excipient used in the manufacture of the product;
(f) a change to the finished product specification of the product;
(g) a change to the test procedure for any raw material used in the manufacture of the product;
(h) a change to the test procedure for the product;
(i) a change to the test procedure for the container or other form of packaging immediately in contact with the product;
(j) a change to comply with a supplement to the European Pharmacopoeia or any national pharmacopoeia of a Member State;
(k) a change to the shape of the container in which the product may be placed on the market;
(l) an additional pack size in which the product may be placed on the market;
(m) a change to the approved storage conditions for the product;
(n) a change to the shelf life of an unopened container of the product after the container has been opened for the first time;
(o) a change to the dimensions of an approved dosage form of the product (for example, tablets); or
(p) a change following modification to the manufacturing authorization referred to in Article 40 of the 2001 Directive.

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Source: https://www.legislation.gov.uk/nisr/2012/134/schedule/2/paragraph/21 (the official version)
Page: https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/schedule-2/paragraph-21
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.